Hydrogen-oxygen generators without a medical device certificate cannot be used! Medical-grade hydrogen-oxygen generators (also known as hydrogen oxygen inhalers or hydrogen oxygen nebulizers ) are medical devices, specifically Class III medical devices (National Medical Device Registration Certificate No. 20203080066/20233081929). Asclepius Meditec’s medical-grade hydrogen-oxygen generator is the only hydrogen inhalation device globally that has received Class III medical device approval. Products that have not obtained medical device certification generally use proton exchange membrane hydrogen production, a method primarily used in fuel cells and unsuitable for medical devices, and therefore unable to pass medical device certification audits.
What are the benefits of a hydrogen-oxygen generator for the human body?
Hydrogen-oxygen medical research has found that inhaling a hydrogen-oxygen mixture has a certain auxiliary effect on diseases of most systems and organs of the human body, potentially offering the possibility of treating different diseases with the same method. The core principle of the Asclepius Meditec’s medical-grade hydrogen-oxygen machine is to generate a mixed gas with a hydrogen-oxygen volume ratio of 66.66%:33.33% through the electrolysis of pure water. Users inhale this gas through a nasal cannula, achieving multiple effects including anti-inflammatory, antioxidant, and improved cellular metabolism. The scientific basis of this principle stems from the unique biological characteristics of hydrogen molecules:
Hydrogen molecules are the smallest molecules in nature, with a diameter of only 10⁻¹⁰ meters, far smaller than the diameter of a cell (10⁻⁶ meters). They can easily penetrate cell membranes and enter the nucleus and mitochondria, precisely neutralizing harmful free radicals in the body (such as hydroxyl radicals •OH and peroxynitrite anions ONOO⁻) [1].
Harmful free radicals are a core factor leading to cell inflammation, oxidative damage, and gene mutations, and are also an important root cause of the occurrence and development of chronic diseases and cancer. Through chemical reduction, hydrogen molecules convert harmful free radicals into harmless water molecules, fundamentally reducing cell damage and restoring normal cellular physiological activity.
The design of hydrogen-oxygen mixed inhalation is scientifically sound: oxygen directly supplements the body's needs and increases blood oxygen saturation; hydrogen reduces airway resistance, improves oxygen utilization, and simultaneously exerts anti-inflammatory effects. The synergistic effect of the two is superior to simply inhaling oxygen or hydrogen alone [2].
Furthermore, hydrogen molecules also have physical effects: firstly, they assist in oxygen diffusion, improving oxygen supply to hypoxic tissues [2], a property that has been utilized in deep-sea diving for over a hundred years; secondly, they act as drug carriers, with animal experiments showing that nebulized inhalation using a hydrogen-oxygen mixture as the gas source results in a 5-20 times higher drug utilization rate compared to oral administration; and thirdly, they have a decomposition effect, inhibiting the formation of vascular plaques and benefiting cardiovascular health. This dual mechanism of "chemical action + physical action" gives hydrogen-oxygen therapy a unique advantage in the intervention of chronic diseases.
What are the dangers of using products that do not have medical device certification?
Using products without a medical device registration certificate may lead to the following risks:
Safety cannot be guaranteed: Without approval and testing by medical device regulatory authorities, the safety and effectiveness of the product cannot be guaranteed, and there may be safety hazards.
Failure to achieve expected results: Products that have not undergone scientific verification and clinical trials cannot guarantee their efficacy and effectiveness, and may fail to achieve the expected therapeutic effects.
Induction of adverse reactions: Using unapproved products may cause adverse reactions, such as allergies and infections, and may even cause serious harm to health.
Therefore, it is recommended that consumers choose legitimate products with a medical device registration certificate or filing certificate when purchasing and using medical-grade hydrogen-oxygen generators, and avoid using unapproved products.
